Kornimate/medical-research-clean huggingface dataset:
body image and sexuality after bariatric surgery

Conditions: Obesity, Morbid; Sexual Dysfunction, Physiological

Summary: sexual desire may decrease among obese individuals who feel worthless and therefore there may be behaviors that avoid sexuality. sexuality, one of the activities of daily life, is an issue that is affected by cultural norms and rules and individuals have difficulties expressing their sexual problems comfortably. in a systematic review which is about the effect of bariatric surgery on sexuality; it was emphasized that bariatric surgery, the most widely used treatment in obesity, has positive effects upon reproductive hormones and sexual functions thanks to weight loss. in light of these information above-mentioned; the study was done to examine the correlation between body perception and sexual life before and after bariatric surgery among obese individuals.

obese individuals who want to learn healthy life behaviors and wish to acquire and to realize behavioral changes that will help them cope with health problems are in need of training and counseling. in this process, nurses -being in close and continuous contact with individuals- play counselor role as a part of their educator roles. it is stated that nurses need to understand, empathize with and support individuals who suffer from different problems while they play this role. in presence of obesity, which is a psychophysiological condition; nurses should also consider the fact that obese individuals who face bitter criticisms and social exclusion may show low self-esteem and impaired body image due to excessive weight and therefore they should give these individuals opportunities to express their feelings as to how they perceive themselves. the studies in literature that investigated the correlation between body mass index (bmi) and self-esteem and body perception report that obese individuals demonstrate relatively lower self-esteem and body perception as compared to the normal individuals. psychological and hormonal disorders, impaired body image and chronic diseases that develop with obesity influence sexual life negatively, too. therefore; sexual desire may decrease among obese individuals who feel worthless and therefore there may be behaviors that avoid sexuality. sexuality, one of the activities of daily life, is an issue that is affected by cultural norms and rules and individuals have difficulties expressing their sexual problems comfortably.

Eligibility criteria:
inclusion criteria: * accepted to join the study, * did not have such psychiatric disorders as anxiety, depression and personality disorders * were aged between 18 and 65. exclusion criteria: * do not accepting to join the study, * have such psychiatric disorders as anxiety, depression and personality disorders * older from 65, under the age of 18.

Keywords: bariatric surgery body image sexuality obesity
coronary sinus reducer in coronary microvascular disease

Conditions: Angina (Stable); Coronary Microvascular Disease

Summary: coronary microvascular dysfunction (cmd) is a common cause of treatment- resistant angina that lacks evidence-based treatment options. the coronary sinus reducer (csr) is an hourglass-shaped stainless steel mesh, designed to create a controlled narrowing of the coronary sinus (cs). by augmenting cs pressure, csr implantation was shown to improve myocardial perfusion, potentially providing a novel treatment for patients with cmd. reduce cmd is a placebo-controlled study of csr in 50 patients with cmd. the main study endpoints are the change in coronary flow reserve from baseline to 6 months in the csr-arm versus the placebo arm, and the difference in number of daily episodes of angina recorded on the orbita-app at 6 month follow-up in the csr-arm versus the placebo arm.


Eligibility criteria:
inclusion criteria: 1. coronary microvascular dysfunction as expressed by abnormal absolute coronary flow reserve (cfr\<2.5) confirmed during the index study procedure using the continuous thermodilution technique and saline-induced coronary hyperemia. 2. no hemodynamically significant epicardial stenoses based on both non-hyperemic pressure ratio (nhpr; ifr\&gt;0.89, or rfr\&gt;0.89, or dfr\&gt;0.89) and fractional flow reserve (ffr\&gt;0.80) assessments. 3. angina - canadian cardiovascular society class ii-iv on maximal medical therapy. 4. negative acetylcholine provocation testing with respect to epicardial or microvascular vasospasm (as such, patients with equivocal acetylcholine provocation test results are not eligible for enrolment). 5. patient understands the nature of the procedure and provides written informed consent prior to enrolment. 6. patient is willing to comply with specified follow-up evaluation. exclusion criteria: 1. age ≤ 40 years. 2. pregnancy. 3. recent acute coronary syndrome (within 3 months). 4. recent revascularization with pci (within 6 months). 5. severe arrhythmias, including chronic atrial fibrillation. 6. severe left ventricular impairment (left ventricular ejection fraction \&lt;25%). 7. permanent pacemaker or defibrillator leads in the right ventricle or atrium. 8. indication for cardiac resynchronization therapy. 9. severe valvular heart disease. 10. history of tricuspid valve replacement or repair. 11. mean right atrial pressure ≥15 mm hg. 12. known allergy to stainless steel or nickel. 13. anomalous or abnormal cs anatomy (e.g., tortuosity, aberrant branch, persistent left superior vena cava). 14. cs diameter at the site of planned implantation greater than 13mm or less than 9.5mm as measured on the venogram. 15. currently enrolled in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with the current study endpoints. 16. life expectancy \<1 year.

Keywords: angina coronary microvascular disease coronary sinus reducer
european registry of anti-epileptic drug use in patients with lennox-gastaut syndrome (lgs)

Conditions: Lennox-Gastaut Syndrome

Summary: this is a registry study, where sites will enter patients with lgs who require a modification in anti-epileptic therapy (either the addition of another anti-epileptic drug, or the change of one drug to another). this will include patients who are started on rufinamide. patients will be reviewed according to local practice, but it is envisaged that review will occur at approximately one month, three months and six months, and then every six months. upon entry to the registry baseline details concerning disease severity, diagnosis, prior therapy, and developmental assessment will be recorded. on each subsequent visit the patient (usually through their caregiver) will be asked about current medication, general seizure profile, any seizures deemed to be of medical significance, tolerability, aes (including suicidal-related events), and healthcare resource utilisation.


Eligibility criteria:
inclusion criteria * patients will be four years and older * patients will have an established diagnosis of lennox-gastaut syndrome, and: * documented history or current presence of multiple seizure types associated with lgs (including tonic or atonic seizures (drop attacks) and atypical absences) * documented history or current presence of typical eeg abnormalities (e.g., bursts of slow spike and wave activity) * presence of intellectual / learning disability (a variable degree is permitted) * patients entered on the registry will be those requiring a modification in their current anti-epileptic medication. this includes but is not limited to patients who are commenced on rufinamide as adjuvant therapy exclusion criteria * female patients who are pregnant, lactating, or whom are planning to become pregnant * female patients, of child bearing potential, who are not willing to use appropriate contraception (this is at the discretion of the investigator) * those starting rufinamide and for whom the investigator considers it necessary to administer in contradiction to the indications, and warnings within the current summary of product characteristics (spc).

Keywords: lennox-gastaut syndrome
effect of repeated feedback to registered nurses pain nursing documentation

Conditions: Education; Nurse's Role; Pain

Summary: the aim of the study is to find out how pain nursing documentation audit and educational feedback effect to rn's pain nursing documentation, the average level of pain nursing documentation knowledge of unit rn's, patient satisfaction of pain management and number of pain nursing incident reports. in addition, how background variables are related to the pain nursing documentation. research hypothesis: pain nursing documentation audit and educational feedback increased rns' pain nursing documentation and knowledge, patient satisfaction to pain management and effect to number of pain nursing incident reports.


Eligibility criteria:
inclusion criteria: * registered nurses (rn) who work at the kuopio university hospital in units of which patients potentially require pain management. exclusion criteria: * professionals other than rn * rn who do not use pain management strategies in their work

Keywords: rn pain nursing pain assessment pain management pain documentation audit and feedback education randomized controlled trial nursing sensitive quality nursing sensitive outcomes
study of the safety, tolerability and immune response of tbe vaccines administered to healthy children

Conditions: Encephalitis, Tick-Borne

Summary: the purpose of this study is to evaluate the safety, immunogenicity and tolerability of tbe vaccines administered to children.


Eligibility criteria:
inclusion criteria: * healthy male and female children, 1 to 10 years of age. exclusion criteria: * subjects with documented evidence of tbe * subjects, who have been previously vaccinated against tbe

Keywords: tbe, children, vaccine
a study evaluating the long-term safety of ica-17043 in sickle cell disease patients with or without hydroxyurea therapy

Conditions: Sickle Cell Disease; Sickle Cell Anemia

Summary: this trial is a follow-up companion study to protocol ica-17043-10, a phase iii, multi-center, efficacy and safety study of ica-17043. this is an open-label extension study collecting safety data on the use of ica-17043 in subjects with sickle cell disease (scd) (e.g., hbss, hbsc, hbsb0-thalassemia, hbsb+-thalassemia subjects). all subjects who have successfully completed ica-17043-10 will, if deemed appropriate by their study investigator and appropriate consent by subject is given, enroll in the ica-17043-12 study (study 12). only patients who participated in ica-17043-10 are eligible for this open label study


Eligibility criteria:
inclusion criteria: * successfully completed study ica-17043-10 * discontinued study 10 or 12 following the dmc recommendations because he/she was not on hu, and has since been on a stable dose of hu for at least 3 months prior to day 1 * male, or female not capable of becoming pregnant or using appropriate birth control * has willingly given written informed consent to participate in this study exclusion criteria: * the subject, if female, has a positive urine pregnancy test on day 1 (before entering study) * the subject is presently unsuitable for participation in this long-term study

Keywords: sickle cell disease sickle cell anemia
observational study regarding adherence, drug use, will to take part in shared decisioning in asthma outpatients

Conditions: Asthma

Summary: in a private practice setting typical for ambulatory medicine in germany, asthma staging according to the gina guidelines will be correlated with "real life" treatment and self management of adult outpatients suffering from asthma. attitudes concerning adherence, awareness, interest in shared decision making and knowledge about the disease are assessed.

the study focuses on outpatients that have two different types of treatment at hand: on-demand reliever treatment and anti-inflammatory treatment. we will assess the correlation of number of devices and medications in regular or intermittent use with doctors recommendations and prescriptions and the parameters adherence, awareness, interest in shared decision making and knowledge about the disease. the patients will be seen two to three times. the first visit is used to inform the patient about the study, to check with regard to inclusion and exclusion criteria, and finally to sign the informed consent, if the patient agrees to be enrolled in the study. the patient then will get the questionnaire, and she or he is asked to collect all asthma related medications in continuous or intermittent use and to bring them to the private practice staff. in the second visit, the private practice staff will check the medications the patient has brought. this is a physical check, i.e. it is based on devices and medications on the desk, not on questions. at least six months later, the private practice staff will check all asthma related prescriptions for the patient concerned, and for the last six months. the patient will be asked to give information if the questionnaire has not been answered completely. in a previous study with 1.670 paediatric outpatients enrolled we have shown under-diagnosis, under-treatment and a low overall effectiveness of paediatric outdoor patient asthma care. in this previous paediatric study we compared suspected diagnosis and reported treatment. we did not assess parameters indicating low or high adherence, nor did we ask for interest in shared decision making or for awareness and indicators for knowledge about the disease.

Eligibility criteria:
inclusion criteria: * age \> 18 years * asthma with irregular or regular use of short acting beta-agonists and/or: * asthma treatment with inhaled steroids * ability to understand the questionnaire exclusion criteria: * age \< 18 years * significant airway disease other than asthma * asthma treatment with fixed combination of inhaled steroids with long or short acting beta-agonists * ability to understand the questionnaire must be doubted

Keywords: single arm observational retrospective and prospective study
follow-up study to assess a second boost immunization with affitope® pd01a with regard to safety and clinical activity (aff008aa)

Conditions: Parkinson's Disease

Summary: this is a follow-up study to assess safety and clinical activity of continued affitope® pd01a vaccinations in patients with parkinson's disease. patients, who have already participated in the aff008 program will be involved and will receive a second boost immunization with affitope® pd01a. one study site in vienna (austria) will be involved. in addition, up to 6 patients will be offered participation within an untreated control group.


Eligibility criteria:
inclusion criteria: * prior participation in aff008, aff008e and aff008a * written informed consent signed and dated by the patient and, preferentially, the caregiver * in the investigator's opinion, does not have visual or auditory impairments that would reduce the patients' ability to complete study questionnaires or be unable to receive instructions for these * female patients of childbearing potential are eligible if they use a medically accepted contraceptive method * all changes in conventional pd therapies must be available to the sponsor; in particular pharmacologic symptomatic pd medication allowing transformation to a levodopa standard dose * a potential participant should be on stable doses of all medications he/she is taking because of consisting illnesses according to medical history (except pd therapies, these will be recorded separately) for at least 30 days prior to visit 1 if considered relevant by the investigator exclusion criteria: * women of childbearing potential without birth control or pregnant women * participation in another clinical trial within 3 months before visit 1 (except aff008a) * history of questionable compliance to visit schedule; patients not expected to complete the clinical trial * autoimmune disease or allergy to components of the vaccine * history of cancer (exceptions: non-melanoma skin cancer, intraepithelial cervical neoplasia) * active infectious disease (e.g., hepatitis b, c) * immunodeficiency * significant systemic illness * alcoholism or substance abuse * prior and/or current treatment with experimental immunotherapeutics including ivig with the exception of affitope® pd01a, with immune modulating drugs or treatment with deep brain stimulation * venous status rendering it impossible to place an i.v. access
5-azacytidine treatment versus 5-azacytidine followed by allogeneic stem cell transplantation in elderly patients with myelodysplastic syndrome (mds)

Conditions: Myelodysplastic Syndrome; Chronic Myelomonocytic Leukemia

Summary: 5-azacytidine treatment prolongs survival in patients with myelodysplastic syndrome (mds), but does not cure the disease. allogeneic stem cell transplantation is a curative treatment option but is associated with a high risk treatment-related morbidity and mortality. in the current trial allogeneic stem cell transplantation will be compared to 5-azacytidine only treatment according to donor availability in elderly patients with mds (55-70 years).

5-azacytidine treatment prolongs survival in patients with myelodysplastic syndrome (mds), but does not cure the disease. allogeneic stem cell transplantation is a curative treatment option but is associated with a high risk treatment-related morbidity and mortality. dose-reduced conditioning prior transplantation allows also treatment of elderly patients with mds. in the current trial allogeneic stem cell transplantation will be compared to 5-azacytidine only treatment according to donor availability in elderly patients with mds (55-70 years).

Eligibility criteria:
inclusion criteria: * patients with proven de novo or therapy-related mds / cmml (wbc \<13 gpt/l)according to fab and risk profile according to ipss: intermediate ii- risk or high-risk or intermediate i with high-risk cytogenetic (according to ipss, taking into account that ipss, however, was not validated for t- mds), patients with secondary aml (according to who) and blasts ≤ 30 % (= raeb-t according to fab) * previously untreated or maximal 1 cycle of 5-azacytidine (vidaza®) * male or female; age 55 - 70 years * understand and voluntarily sign an informed consent form * ecog performance status of ≤ 2 at study entry * adequate renal and liver function: creatinine and bilirubin \< 3 x the upper limit of normal * sufficient cardiac function (ejection fraction \> 30 %) exclusion criteria: * blasts \> 30 % in bone marrow at time of diagnosis * central nervous involvement * severe irreversible renal, hepatic, pulmonary or cardiac disease, such as * total bilirubin, sgpt or sgot ≥ 3 times upper the normal level * left ventricular ejection fraction \< 30 % * creatinine clearance \< 30 ml/min * dlco \< 35 % and/or receiving supplementary continuous oxygen * pregnant or breastfeeding female subject * patients with a life-expectancy of less than six months because of another debilitating disease * serious psychiatric or psychological disorders * uncontrolled invasive fungal infection at time of registration * known positive for hiv or acute infectious hepatitis, type a, b or c * participation in another study with ongoing use of unlicensed investigational product from 28 days before study enrollment until the end of the study

Keywords: mds cmml allogeneic stem cell transplantation 5-azacytidine
physiotherapy treatment for chronic achilles tendinopathy

Conditions: Achilles Tendinopathy

Summary: laser treatment with the proper dosage has been found effective in the treatment of chronic achilles tendinopathy, and animal research indicate that a combination of cryotherapy followed by lllt could yield an even better result. thus, the main purpose of this project is to test if the addition of low level laser therapy can enhance the treatment result of exercise and cryotherapy in patients with chronic achilles tendinopathy, yielding less pain and higher function.


Eligibility criteria:
inclusion criteria: * achilles tendinopathy with a minimum duration of three months, pathological appearance of the achilles tendon with thickened tendon and structural changes of the tendons matrix. exclusion criteria: * cortisone injection within the last 6 months, systemic inflammatory disease, previous suture/surgery of the achilles tendon, pregnancy or familial hypercholesterolemia.

Keywords: chronic tendinopathy low-level laser therapy lllt photobiomodulation cryotherapy exercise therapy randomized clinical trial rct placebo-controlled
the effect of probiotics in hiv-1 infection

Conditions: HIV-1 Infection

Summary: hiv progression is closely associated with chronic immune activation driven by leakage of bacterial products from a damaged gut, the investigators largest immunological organ. notably, the degree of immune activation has been suggested to be a better predictor of disease progression than plasma viral load, and markers of immune activation and gut damage have been identified as therapeutic targets per se. the major damage by hiv to the immune system is an initial massacre of gut mucosal cd4+ th17 cells. interestingly, a normal gut flora has been shown to induce the maturation of th17 cells in the small intestine mucosa. preliminary reports have shown that the gut flora is altered in hiv-1 infection compared to controls. in this project, the investigators will characterize microbial composition of gut flora in chronic hiv infection with ultradeep sequencing. gut flora composition will be related to clinical data as well as quantitative data of circulating microbial products and activation markers. second, in a randomized clinical trial (rct) the effect of probiotic lactobacilli on hiv pathogenesis and progression will be tested. this gram-positive strain is clinically tested and is able to colonize the gut.

objectives: to explore (i) the safety and tolerability, and (ii) the efficacy of probiotics on hiv-associated microbial translocation, systemic immune activation, disease progression and composition of gut microbiota in chronic hiv-1 infection. methodology/study design: approximately 50 patients without current indication for antiretroviral treatment (art) and 50 patients receiving art without normalised cd4 counts will be included. a controlled clinical trial will be carried out within each stratum randomised in a 2:1:1 fashion to double blinded intervention and placebo arms as well as an open, untreated control arm, respectively.

Eligibility criteria:
inclusion criteria: * for patients without art: confirmed diagnosis of hiv infection \> 6 months and cd4+ t cell count \< 900 * for patients on stable, effective art: hiv rna \ 6 months and cd4+ t cell count \> 500 * signed informed consent. exclusion criteria: * severe illness requiring hospitalization * systemic antibiotics or probiotics the last two months * current immune modulating therapy * infectious diarrhea * inflammatory bowel disease * acute primary hiv infection * patients immigrating from africa, asia or latin-america within the last 6 months.

Keywords: hiv microbial translocation immune activation probiotics